Sweat Patch Validation

Validity of a Prototype Wearable Patch in Measuring Local Sweating Rate and Sweat Electrolyte Concentration During Exercise

To determine the validity of a prototype patch in measuring sweating rate and sweat electrolyte concentration during moderate intensity exercise against well-established reference methods in a controlled laboratory and in field conditions.

Study Overview

• Status: Completed
• Conditions: Sweat Analysis
• Intervention / Treatment: Other: Sweat patch

• Study Type: Interventional
• Enrollment (Actual): 552
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34210
      • Gatorade Sports Science Institute at IMG Academy
  • Illinois
    • Barrington, Illinois, United States, 60010
      • Gatorade Sports Science Institute (GSSI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is male or female
• Subject is 15-45 years
• Subject is moderately-trained (engages in moderate-intensity, intermittent, or steady-state exercise at least 4 days per week for at least 1 hour at a time)
• Subject is capable of moderate-intensity, intermittent exercise for 1-2 hours as assessed by recent training history
• If participating in Study Session 1, 2, 3, or 4, subject has a treadmill VO2max ≥ 42 ml/kg/min if male or ≥ 38 ml/kg/min if female, as measured during the screening at the GSSI laboratory
• If participating in Study Session 1, 2, 3, or 4, subject has a normal fasting blood glucose (70-110 mg/dl), as measured during the screening at the GSSI laboratory
• If participating in Study Session 1, 2, 3, or 4, subject has a normal resting blood pressure (< 140/90 mmHg), as measured during the screening at the GSSI laboratory
• If participating in Study Session 1, 2, 3, or 4, subject has a normal resting and graded exercise EKG, as measured during the screening at the GSSI laboratory
• If participating in Study Session 1, 2, 3, or 4, willing to be shaved at patch sites
• If participating in Study Session 3 or 4, willing to undergo a nude shower by an investigator of the same sex for collection of sweat electrolytes in the whole body wash procedure
• If participating in Study Session 5 or 6, subject is a trained team-sport athlete currently participating in training/competition at IMG Academy

Exclusion Criteria:

• Subject is pregnant (self-reported)
• Subject is a smoker
• Subject has a body weight that is lighter than 80 pounds
• Subject has a known or suspected obstructive disease of the gastrointestinal tract, such as diverticulitis or inflammatory bowel disease
• Subject has a history of problems with the gag reflex
• Subject has not had previous gastrointestinal surgery
• Subject has problems with swallowing
• Subject is planning to have an MRI scan during the time that the CorTemp™ Core Body Temperature Sensor is in the body
• Subject has slow movement of the gastrointestinal tract
• Subject has a cardiac pacemaker or other implanted electronic device
• Subject has asthma or other condition in which breathing can become difficult/labored during exercise (applies to Study Session 1-4 only)
• Subject is allergic to adhesives
• Subject is currently taking a medication or oral supplement that could interfere with study results
• Subject has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
• Subject has been enrolled into a PepsiCo-sponsored study within the past six months
• Subject has been enrolled into a clinical trial at a laboratory or clinic other than PepsiCo within the past 30 days
• Subject is employed by, or has a parent, guardian or other immediate family member employed by, a company that manufactures any products that compete with any Gatorade products. If subject is unsure if a company would be considered a competitor to Gatorade they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Study Session 1; Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the laboratory	Other: Sweat patch; Flexible, epidermal, wearable skin patch to collect and analyze sweat
OTHER: Study Session 2 (repeat of Study Session 1); Arm Type: Validation: Regional sweat collection with prototype vs. reference patch in the laboratory	Other: Sweat patch; Flexible, epidermal, wearable skin patch to collect and analyze sweat
OTHER: Study Session 3; Arm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory	Other: Sweat patch; Flexible, epidermal, wearable skin patch to collect and analyze sweat
OTHER: Study Session 4 (repeat of Study Session 3); Arm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory	Other: Sweat patch; Flexible, epidermal, wearable skin patch to collect and analyze sweat
OTHER: Study Session 5; Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field	Other: Sweat patch; Flexible, epidermal, wearable skin patch to collect and analyze sweat
OTHER: Study Session 6 (repeat of Study Session 5); Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field	Other: Sweat patch; Flexible, epidermal, wearable skin patch to collect and analyze sweat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sweat chloride concentration	Prototype vs. reference method (regional absorbent patch technique) during exercise	1.5 hours in sessions 1-6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional sweating rate	Prototype vs. reference method (gravimetry using the regional absorbent patch technique) during exercise	1.5 hours in sessions 1-6
Whole body sweating rate	Prototype vs. reference method (changes in nude body mass corrected for fluid intake, urine output, respiratory water loss, and metabolic mass loss) during exercise	1.5 hours in sessions 1-6
Whole body sweat chloride concentration	Prototype vs. reference method (whole body washdown technique) during exercise	1.5 hours in sessions 3-4
Whole body sweat sodium concentration	Reference method only. Compare whole body sweat chloride concentration vs. whole body sweat sodium concentration during exercise	1.5 hours in sessions 3-4
Self-ratings of perceived sweating vs. measured sweating rate	Multiple choice questionnaire vs. sweat patch analysis	Prior to the start of exercise at sessions 1-6
Self-ratings of perceived sweat saltiness vs. sweat electrolyte concentrations	Multiple choice questionnaire vs. sweat patch analysis	Prior to the start of exercise at sessions 1-6
History of exercise-associated muscle cramps	Multiple choice questionnaire	Prior to the start of exercise at sessions 1-6

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Lindsay B Baker, PhD, PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) PI for Barrington site; Principal Investigator: Khalil Lee, PhD, PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) PI for Bradenton site

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2017
• Primary Completion (ACTUAL): October 24, 2020
• Study Completion (ACTUAL): October 24, 2020

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: wearable; epidermal; sweating rate; sweat electrolytes; sweat patch; sweat electrolyte concentrations
• Other Study ID Numbers: PEP-1714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No